VivaChek Blood Glucose and B-Ketone Monitoring System— 510(k) K192957
Substantially EquivalentVivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K192957 for VivaChek Blood Glucose and B-Ketone Monitoring System, Substantially Equivalent on 2020-06-05. Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code JIN
view all- K201551 — KetoSens BT Blood B-Ketone Monitoring System
- K182593 — KET-1 Blood Ketone Monitoring System
- K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
- K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
- K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
More clearances from Vivachek Biotech (Hangzhou) Co., Ltd.
view all- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
- K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
- K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
Data sourced from openFDA. This site is unofficial and independent of the FDA.